Kornimate/medical-research-clean huggingface dataset:
study to evaluate broadlumab vs placebo and ustekinumab

Conditions: Psoriasis

Summary: the purpose of the study is to evaluate the efficacy and safety of induction and maintenance regimens of brodalumab compared with placebo and ustekinumab in subjects with moderate to severe plaque psoriasis.

the study is up to 5 years. if you qualify, you will be randomized into 1 of 4 groups. two groups will get brodalumab(1 group will get 210milligrams of brodalumab at each dose and the other group will get 140 milligrams of brodalumab at each dose), one group will get ustekinumab, and one group will get placebo.

Eligibility criteria:
inclusion criteria: * subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of ip. * subject has involved body surface area \>_10%, pasi\>_, and spga\>_3 at screening and at baseline. * for women, a negative serum pregnancy test during screening a negative urine pregnancy test at baseline. * subject has no known history of active tuberculosis. * subject has a negative test for tuberculosis during screening. exclusion criteria: * subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit that would interfere with evaluations of the effect of ip on psoriasis. * subject has a planned surgical intervention between baseline and the week 52 evaluation. * subject an active infection or history of infections. * subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled. * subject has known history of crohn's disease. * subject has known history of hepatitis b, hepatitis c, or human immunodeficiency virus. * subject had myocardial infarction or unstable angina pectoris within the past 12 months prior to the first dose of ip. * subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. * subject has history of malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma. * subject has received live vaccine(s) within 28 days of the first dose of ip. * subject has used ustekinumab and/or antio-il-17 biologic therapy ever or other experimental or commercially available biologi immune modulator(s) within 12weeks prior to the first ip dose * subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s). * for women not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose. * for women; pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose.

Keywords: psoriasis
an in-vitro real-time system based on tissue smears to identify malignancy during hysteroscopic procedure

Conditions: Uterine Cervical Neoplasm; Uterine Neoplasms

Summary: the aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.


Eligibility criteria:
inclusion criteria: * patients undergoing hysteroscopy exclusion criteria: * pregnancy
synbiotics in advanced hiv infection

Conditions: HIV Infection Asymptomatic

Summary: late diagnosed hiv-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. gut bacteria metabolism appears to impact immune recovery in hiv-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. this is a pilot multicenter randomized placebo-controlled, double blind clinical trial in hiv-infected art-naive subjects with \<350 cd4 t cells/mm3 or aids. participants will be randomized (1:1) to either the synbiotic nutritional supplement pmt25341 or placebo for 48 weeks, each in combination with first-line art. primary outcomes will be safety and immunological recovery. secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.


Eligibility criteria:
inclusion criteria: * hiv-infected art-naive subjects with \<350 cd4 t cells/mm3 or aids * initiating art with any first-line regimen recommended in the spanish gesida national guidelines exclusion criteria: * age \<18 years * pregnancy * type 1 or 2 diabetes * end-stage renal disease * lactose intolerance * use of immunomodulatory drugs * neutrophil count \<750cells/ul

Keywords: hiv immunologic recovery microbiota prebiotics probiotics synbiotics
balance in individuals with pes planus

Conditions: Pes Planus

Summary: pes planus, one of the most common biomechanical disorders in the lower extremities, negatively affects the daily life of the individual and their competence in activities. the aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus.

methods: 22 volunteer patients diagnosed with pes planus in medipol mega university hospital physical therapy and rehabilitation clinic will be included in the study. this study was approved by medipol university non-interventional clinical research ethics committee at the meeting numbered 10840098-604.01.01-e.63688 with decision number 1027. approved. the signatures of the participants included in the study were given with the "informed voluntary consent form". oral and written about the research. with the "participant diagnosis form", the person's name-surname, age, gender, height, weight, body mass index, contact number, pes planus degree, whether he has a diagnosed disease, whether he has a past disability or whether he has had surgery will be questioned. . in the 30-45 age group, 22 volunteers with pes planus and 24 volunteers without pes planus will be included in the study. individuals in the pes planus group will be formed at the 2nd and 3rd levels by a single physiotherapist with clinical experience, based on the feiss line in pes planus.

Eligibility criteria:
inclusion criteria: * healthy volunteers, aged between 30-45 years, have not had any lower extremity injury in the last 6 months, have not had any chronic lower extremity pain, have not undergone any lower extremity surgery, and have signed an informed consent form. exclusion criteria: * those with central nervous system and visual pathology that may affect balance, patients with vestibular pathology, deformities in the waist, hip or knee joints, amputation in the lower extremity, history of lower extremity surgery, malignancy affecting the lower extremity, those who cannot communicate, those who use assistive walking devices are obese patients were not included.

Keywords: pes planus, balance, static balance, dynamic balance
heparin free haemodialysis with haemodialyzers "vie" versus "evodial"

Conditions: Adult Chronic Haemodialysis Patients Since at Least 3 Months

Summary: the adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. in the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. the heparin coated polyacrylonitrile haemodialyser (evodial) has been reported to have 90 % successful heparin-free haemodialysis sessions. on the other hand, the vitamin e coated polysulphone (vie) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. this randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer vie 2,1 versus evodial2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.


Eligibility criteria:
inclusion criteria: -- adult chronic haemodialysis patients since al least 3 months * two needles puncture of the fistula, * low molecular weight heparinization during haemodialysis sessions, * good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min), * systolic blood pressure ≥ 110 mmhg (mean value of three last dialysis sessions. * patients capable to understand the design of the study and to follow the instructions * patients having the french social security system affiliation. non-inclusion criteria : * c reactive protein \> 30 mg/l. * single needle puncture of the fistula * active documented haemorrhage, * haemoglobin \< 10 g/dl and/or need blood transfusion, * documented thrombophilia * patients waiting for renal graft * acute sepsis * fistula or catheter dysfunction * patients under anti-vitamine k * per dialytic hypotension requiring al least once a nurse intervention, * severe diseases (dysglobulinemia, vascularitis, hiv...), * patients following another research protocol or have ended one less then one month before starting of this study. * pregnant or breast feeding patients, * minor patients or under law-protection
heparin-induced thrombocytopenia score card study

Conditions: Heparin-Induced Thrombocytopenia

Summary: main research question: can two new types of test, one called the 4t's score and the other called a rapid assay, help doctors correctly identify which patients are unlikely to have heparin-induced thrombocytopenia (hit)? hit is a severe allergic reaction to the blood thinner heparin. this allergic reaction can lead to heart attacks, strokes, limb amputations, and death. because heparin is one of the most commonly used drugs in the hospital setting, it is very important that the investigators are able to correctly identify who can safely continue to take heparin and who cannot. it can be very difficult to diagnose hit because it can look like many other medical conditions and the best laboratory tests for hit are difficult to run and only available at specialized centres. it would be very helpful if doctors had tests they could use that would tell them quickly and accurately which patients with symptoms that look like hit really do have hit (and require urgent treatment with another type of blood thinner) and which patients are very unlikely to have hit (and could continue to take heparin safely). in this study, the investigators will compare the 4t's score (a scoring system that assigns "points" to the presence or absence of specific clinical features) and a rapid laboratory test with the old laboratory test to find out if one or both of these types of tests are useful for telling doctors which patients have hit and which patients don't have hit.


Eligibility criteria:
inclusion criteria: * suspected heparin-induced thrombocytopenia exclusion criteria: * unable to give consent * unable to provide a blood sample * previous entered in study

Keywords: diagnosis
early non-invasive ventilation outside the intensive care unit

Conditions: Early Acute Respiratory Failure

Summary: a large multicentre, randomized, controlled trial to demonstrate that non invasive ventilation given at an early stage of acute respiratory failure (arf) outside the intensive care unit (icu) can prevent the deterioration of arf and the need for icu when compared to the best available treatment usually performed in the non-icu wards.


Eligibility criteria:
inclusion criteria: * informed consent * age \>= 18 years * admission in a non-intensive-care department * radiological evidence of new pulmonary consolidation or atelectasis * peripheral oxygen saturation less than 92% while breathing room air or pao2/fio2 ratio less than 300 at blood gas analysis * decompensated hypercapnia (pco2 \> 45 mmhg and ph \< 7.35) * clinical signs of respiratory distress (dyspnoea, utilization of accessory respiratory muscles, paradox movements of thoraco-abdominal wall) in air. exclusion criteria: * respiratory failure due to chronic obstructive pulmonary disease exacerbation, defined as paco2 \> 45 and ph \< 7.35 (in these patients niv is considered to be the standard/first line treatment and we do not want to deny these patients the opportunity to receive this treatment because of randomization) * severe, hypercapnic arf defined as paco2 \> 45 and ph \< 7.30 * severe, hypoxic arf defined as pao2/fio2 \< 200 * need for immediate mechanical ventilation or icu as judged by the icu physician in charge * extremely poor short term prognosis (imminent death with decision for palliative treatment only) * invasive or non-invasive mechanical ventilation during the same hospitalization due to respiratory failure. * clear contraindication to niv treatment: respiratory arrest, failure to correct positioning of a face mask, hemodynamic instability due to hypotensive shock, ongoing myocardial ischemia, arrhythmia, massive bleeding from upper gastrointestinal tract, patient uncooperative and upset, inability to protect airways, alterations of deglutition, inability to clear secretion also with external aspiration, multiple organs dysfunction, recent surgery of airways or upper gastrointestinal tract, not-drained pneumothorax, bowel obstruction, active vomit.

Keywords: niv acute respiratory failure hypoxia hypercapnia non-invasive ventilation hospital ward
reconstruction implant bone after removal using porous titanium prosthesis

Conditions: Otorhinolaryngologic Diseases

Summary: this trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity. the implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.


Eligibility criteria:
inclusion criteria: * male or female more than 18 years old exclusion criteria: * age less than 18 years old * pregnant women * local carcinoma excluding radiotherapic or surgical control * poor general condition * contraindication to general anesthesia * uncontrolled diabetes

Keywords: porous titanium implants thyroplasty vocal cord paralysis male or female more than 18 years old
treatment of depressed women who have been sexually abused

Conditions: Depression

Summary: the purpose of this study is to compare schema-focused therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

schema-focused (sf) therapy is an extension of cognitive therapy that was developed to address the treatment needs of patients with long-standing mental disorders. sf therapy focuses on early maladaptive schemas (ems): broad, pervasive themes regarding oneself and one's relationship with others, developed during childhood and elaborated throughout one's lifetime, which are dysfunctional to a significant degree. sf therapy involves the identification of the particular ems that is most relevant for each patient and attempts to modify the relevant schemas by altering the distorted views of self and others. participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months posttreatment. the severity of depressive symptomatology is measured and a self-report beck depression inventory is administered. at the end of the study and at the follow-up intervals, participants are given the longitudinal interval follow-up evaluation, an instrument that assesses the severity of depression and dysthymia symptoms.

Eligibility criteria:
inclusion criteria: * major depression * history of childhood sexual abuse

Keywords: child abuse, sexual
safety and efficacy of nmd670 in adult patients with type 1 and type 2 charcot-marie-tooth disease

Conditions: Charcot-Marie-Tooth Disease

Summary: this phase 2a study aims to evaluate the efficacy, safety and tolerability of nmd670 vs placebo administered twice a day (bid) for 21 days in ambulatory adult patients with charcot-marie-tooth disease type 1 and type.


Eligibility criteria:
inclusion criteria: * male or female participants must be 18 to 70 years inclusive at the time of signing the icf. * diagnosis of cmt type 1 or 2 confirmed by genetic testing. * body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg * contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * participant is capable of and has given signed informed consent exclusion criteria: * participants with other significant disease that may interfere with the interpretation of study data (e.g., other neuromuscular diseases) and/or ability to complete the tests, in the opinion of the investigator. * participants with laboratory test result abnormalities at screening considered clinically significant by the investigator. * participants who have received treatment with another imp within 30 days (or 5 half-lives of the medication, whichever is longer) prior to day 1. * participants with history of poor compliance with relevant therapy in the opinion of the investigator. * female participants who plan to become pregnant during the study or are currently pregnant or breastfeeding.
reduction of endometritis after cesarean section with the routine use of methergine

Conditions: Endometritis

Summary: endomyometritis is an "infection in the uterus". it can occur in up to 1 out of 5 women having unplanned cesarean deliveries. antibiotics are routinely given at the time of cesarean delivery, but the infection in the uterus can still occur. when endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. methergine works by contracting (tightening) the uterus. these contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection. this research study is being done to learn if routine use of methergine can lower the chances of developing a uterine infection after cesarean delivery. half of the women in this study will receive methergine for a few days during their hospitalization after cesarean delivery. the other half of the women will not routinely receive methergine.


Eligibility criteria:
inclusion criteria: 1. female singleton gravidas 2. patients receiving non-elective cesarean deliveries after trial of labor 3. no evidence of chorioamnionitis exclusion criteria: 1. diagnosis of chorioamnionitis 2. elective cesarean section 3. unable to provide informed consent 4. immunocompromised patients and those on antiretroviral drugs 5. patients with known infection 6. hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or preeclampsia. 7. allergic to ergot alkaloids. this would include people allergic to migraine medicine.
modulation of propofol injection pain by rubbing and distraction

Conditions: Propofol Injection; Pain; Rubbing; Distraction

Summary: this prospective randomized controlled study will be conducted to evaluate the effects of rubbing and distraction on the incidence and severity of propofol injection pain and compare them with the standard intravenous lidocaine method.

propofol has become one of the most common anesthetic agents used for sedation, induction, and maintenance of anesthesia because of its unique pharmacological properties. pain during bolus injection is a major drawback with an incidence as high as 80%-90% in an untreated patient. one of the most effective factors that alleviate the injection pain involves pretreatment with lidocaine. spinal modulation of pain is explained by the melzack gate control theory, it proposed that stimulation of a beta fibers by touch and vibration, modulate the dorsal horn "gate" and therefore the nociceptive input from the periphery could be reduced. (5) regarding the use of this concept for managing propofol pain, only one study was conducted and revealed that rubbing didn't decrease the incidence but significantly decreased the severity of pain. distraction is a method of removing attention; so, it modifies cognitive pain perceptions by altering nociceptive responses and triggering an internal pain-suppressing system. therefore, it causes a decrease in the activation of areas in the brain (e.g.: thalamus and insula) which contribute significantly to pain perception. we will combine rubbing and distraction, as methods for spinal and supra-spinal pain modulation, to evaluate their effects on propofol injection pain and compare them with the standard intravenous lidocaine method.

Eligibility criteria:
inclusion criteria: * patients of either sex * american society anesthesiologists physical (asa) status i-ii * age between 18-65 years old * undergoing elective surgeries under general anesthesia using propofol for anesthetic induction. exclusion criteria: * allergy to experimental drugs * abuse of alcohol, analgesia, or sedative antidepressant * difficulty in communication * chronic pain syndromes, thrombophlebitis, neurological disease, and analgesic administration at the time of the study

Keywords: pain, modulation